Acetaminophen; Oxycodone Hydrochloride

Sold as Xartemis Xr. Every FDA application for this active ingredient: 1 branded and 65 generic.

As of Nov 15, 2026, FDA lists 66 applications for Acetaminophen; Oxycodone Hydrochloride (sold as Xartemis Xr), first approved Mar 11, 2014, with 0 new uses approved and 0 published complete response letters.

First approved: Mar 11, 2014
Applications: 66
New uses approved: 0
Complete response letters: 0

Clinical Trials

59 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Physical Therapy for the Management of Postoperative Pain After Minimally Invasive Thoracic SurgeryPost Operative Pain · University of Miami	Phase 4	Not yet recruiting	Nov 12, 2026
A Pilot Randomized Controlled Trial of Suzetrigine as an Adjunct to Multimodal Analgesia Following Total Knee ArthroplastyTotal Knee Arthroplasty · University of California, Irvine	Phase 4	Not yet recruiting	Nov 10, 2026
Suzetrigine for Analgesiain Arthroscopic Rotator Cuff RepairArtroscopic Surgery, Pain Management · University of Alabama at Birmingham	Phase 4	Not yet recruiting	Oct 8, 2026
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)Pain Management · Merck Sharp & Dohme LLC	Phase 2	Not yet recruiting	Oct 7, 2026
Suzetrigine Versus Standard Analgesia After Skin Cancer SurgeryPostoperative Pain, Acute Pain · University of Minnesota	Phase 4	Not yet recruiting	Sep 25, 2026
Post-Vasectomy Pain StudyVasectomy, NSAIDs · Columbia University	Phase 1	Recruiting	Sep 17, 2026
Suzetrigine in Tonsillectomy for Opioid-sparing Pain ManagementTonsillectomy, Pharyngoplasty · Stanford University	Phase 4	Not yet recruiting	Sep 16, 2026
Post-op Analgesia of Nail Unit ProceduresNail Diseases · University of Miami	Phase 4	Not yet recruiting	Sep 15, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Aug 31, 1976	PercocetANDA 85106	Ozantri	23	Discontinued
Oct 25, 1977	Oxycodone 2.5/Apap 500ANDA 85910	Bristol Myers Squibb	0	Discontinued
Oct 25, 1977	Oxycodone 5/Apap 500ANDA 85911	Bristol Myers Squibb	0	Discontinued
Feb 25, 1980	RoxicetANDA 87003	Hikma	32	Discontinued
Nov 2, 1981	Oxycodone And AcetaminophenANDA 87406	Barr	23	Discontinued
Dec 7, 1983	OxycetANDA 87463	Specgx LLC	33	Marketed
Nov 8, 1984	Tylox-325ANDA 88246	Ortho Mcneil Pharm	0	Discontinued
Dec 12, 1984	TyloxANDA 88790	Janssen Pharms	8	Discontinued
Dec 3, 1986	RoxicetANDA 89351	Hikma	31	Discontinued
Jan 12, 1989	Roxicet 5/500ANDA 89775	Roxane	9	Discontinued
May 4, 1989	Oxycodone And AcetaminophenANDA 89994	Halsey	1	Discontinued
Jul 3, 1995	RoxiloxANDA 40061	Roxane	7	Discontinued
Jul 30, 1996	Oxycodone And AcetaminophenANDA 40105	Ph Health	17	Discontinued
Jul 30, 1996	Oxycodone And AcetaminophenANDA 40106	Vintage Pharms	2	Discontinued
Oct 30, 1997	Oxycodone And AcetaminophenANDA 40171	Watson Labs	18	Discontinued
Oct 30, 1997	Oxycodone And AcetaminophenANDA 40234	Watson Labs	3	Discontinued
Jan 22, 1998	Oxycodone And AcetaminophenANDA 40219	Mutual Pharm	8	Discontinued
Jun 30, 1998	Oxycodone And AcetaminophenANDA 40272	Duramed Pharms Barr	3	Discontinued
Aug 4, 1998	Oxycodone And AcetaminophenANDA 40257	Mallinckrodt	1	Discontinued
Dec 30, 1998	Oxycodone And AcetaminophenANDA 40199	Actavis Elizabeth	0	Discontinued
Mar 15, 1999	Oxycodone And AcetaminophenANDA 40203	Actavis Elizabeth	15	Discontinued
Mar 16, 1999	Oxycodone And AcetaminophenANDA 40289	Duramed Pharms Barr	6	Discontinued
Jun 25, 1999	PercocetANDA 40330	Ozantri	25	Marketed
Jul 26, 1999	PercocetANDA 40341	Vintage Pharms LLC	10	Discontinued
Dec 30, 1999	Oxycodone And AcetaminophenANDA 40303	Vintage Pharms LLC	2	Discontinued
Oct 2, 2000	Oxycodone And AcetaminophenANDA 40304	Barr	0	Discontinued
Dec 29, 2000	Oxycodone And AcetaminophenANDA 40371	Watson Labs	1	Discontinued
Sep 5, 2003	Oxycodone And AcetaminophenANDA 40535	Watson Labs	17	Discontinued
Jun 30, 2004	Oxycodone And AcetaminophenANDA 40545	Specgx LLC	16	Marketed
Jun 30, 2004	Oxycodone And AcetaminophenANDA 40550	Mallinckrodt	0	Discontinued
Dec 30, 2005	Oxycodone And AcetaminophenANDA 40608	Pharmobedient	15	Marketed
Apr 19, 2006	Oxycodone And AcetaminophenANDA 40676	Mikart	0	Discontinued
Apr 27, 2006	Oxycodone And AcetaminophenANDA 40687	Mikart	0	Discontinued
Apr 27, 2006	Oxycodone And AcetaminophenANDA 40692	Mikart	0	Discontinued
Apr 27, 2006	Oxycodone And AcetaminophenANDA 40698	Mikart	0	Discontinued
May 16, 2006	Oxycodone And AcetaminophenANDA 40679	Mikart	0	Discontinued
Sep 29, 2006	Oxycodone And AcetaminophenANDA 40680	Specgx LLC	9	Discontinued
Nov 27, 2007	Oxycodone And AcetaminophenANDA 40789	Amneal Pharms Ny	0	Discontinued
Nov 27, 2007	Oxycodone And AcetaminophenANDA 40778	Amneal Pharms Ny	15	Marketed
Nov 27, 2007	Oxycodone And AcetaminophenANDA 40777	Amneal Pharms	15	Marketed
Oct 20, 2008	Oxycodone And AcetaminophenANDA 90177	Dr Reddys Labs SA	9	Discontinued
Apr 3, 2012	Oxycodone And AcetaminophenANDA 40800	Actavis Elizabeth	14	Discontinued
Jul 26, 2012	Oxycodone And AcetaminophenANDA 202677	Alvogen	13	Marketed
Apr 12, 2013	Oxycodone And AcetaminophenANDA 201447	Actavis Elizabeth	14	Marketed
Jul 11, 2013	Oxycodone And AcetaminophenANDA 90733	Ph Health	14	Discontinued
Jul 11, 2013	Oxycodone And AcetaminophenANDA 90734	Ph Health	14	Discontinued
Jul 15, 2013	Oxycodone And AcetaminophenANDA 201972	Aurolife Pharma LLC	15	Marketed
Dec 26, 2013	Oxycodone And AcetaminophenANDA 90535	Sun Pharm Inds Inc	13	Discontinued
Mar 11, 2014	Xartemis XrNDA 204031 · New dosage form	Mallinckrodt Inc	5	Discontinued
Aug 28, 2014	Oxycodone And AcetaminophenANDA 201278	Rhodes Pharms	12	Marketed
Dec 18, 2014	Oxycodone Hydrochloride And AcetaminophenANDA 203573	Ph Health	14	Discontinued
Dec 13, 2016	Oxycodone And AcetaminophenANDA 207574	Pharmazone	11	Discontinued
Feb 24, 2017	Oxycodone And AcetaminophenANDA 204407	Novel Labs Inc	10	Marketed
Mar 22, 2017	Oxycodone And AcetaminophenANDA 207419	Ascent Pharms Inc	12	Marketed
Sep 25, 2017	Oxycodone And AcetaminophenANDA 207333	Lannett Co Inc	10	Marketed
Dec 28, 2017	Oxycodone And AcetaminophenANDA 210079	Nesher Pharms	4	Discontinued
Feb 9, 2018	Oxycodone And AcetaminophenANDA 210644	Abhai LLC	9	Marketed
Mar 21, 2018	Oxycodone And AcetaminophenANDA 207510	Wes Pharma Inc	12	Marketed
Jul 2, 2018	Oxycodone And AcetaminophenANDA 203864	Epic Pharma LLC	7	Marketed
Jul 2, 2018	Oxycodone And AcetaminophenANDA 209385	Elite Labs Inc	11	Marketed
Nov 27, 2018	Oxycodone And AcetaminophenANDA 202142	Pharmobedient	8	Marketed
Dec 31, 2018	Oxycodone And AcetaminophenANDA 211499	Abhai LLC	7	Marketed
Aug 15, 2019	Oxycodone And AcetaminophenANDA 207834	Chartwell	4	Discontinued
Oct 31, 2019	Oxycodone And AcetaminophenANDA 211708	Granules	9	Marketed
Aug 26, 2021	Oxycodone And AcetaminophenANDA 201448	Sankalp Lifecare	7	Discontinued
—	Acetaminophen; Oxycodone HydrochlorideANDA 207113	Actavis Labs Fl Inc	0	Discontinued

Show all 66

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA